An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2015 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruitment status was: Active, not recruiting

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT01772823

First Posted: January 21, 2013

Last Update Posted: November 21, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to more closely monitor longer-term outcome of potential concerns.

Change in serum creatinine from baseline, bone mineral density change from baseline, and change in behavioral disinhibition/risk compensation endpoints (e.g., number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner)

Acceptability, patterns of use, rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. [ Time Frame: 48 weeks ]

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

Feasibility of PrEP as measured by process indicators (e.g., number of subjects screened, number eligible, number enrolled, and number choosing to take PrEP)

Medication adherence as measured by number of days of missed medication per total number of days, period of time that a subject's supply of study medication is assumed to be exhausted based on refill dates, and levels of drug exposure as measured by dried blood spot, plasma and peripheral blood mononuclear cell (PBMC) samples.

Behavioral disinhibition/risk compensation [ Time Frame: 48 weeks ]

Changes in behavioral disinhibition/risk compensation as measured by number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner etc.

Secondary Outcome Measures:

Acceptability and feasibility of two types of efficacious sexual risk reduction interventions as measured by session evaluation (i.e., was session interesting, was it relevant to their life, and did they learn from the session) [ Time Frame: 48 weeks ]

Acceptability and feasibility of text message reminders as measured by subject rating of the reasons for missing medications on a 4-point Likert scale. [ Time Frame: 48 weeks ]

Explore potential demographic and/or behavioral differences between youth who are interested in participating in a PrEP study versus those who are not. Behavioral disinhibition/risk compensation endpoints will be compared. [ Time Frame: 48 weeks ]

3MV Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP

Behavioral: 3MV

Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Other Name: Many Men, Many Voices

Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))

All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

Other Names:

FTC/TDF

Truvada®

Emtricitabine/tenofovir

PrEP

Experimental: PCC Behavioral Intervention Group

PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP

Behavioral: PCC

Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.

Other Name: Personalized Cognitive Counseling

Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))

All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

Other Names:

FTC/TDF

Truvada®

Emtricitabine/tenofovir

PrEP

Detailed Description:

The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of PrEP from prior studies.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 22 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Willing and able to provide written informed consent;

Male gender at birth;

Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent;

Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;

Anal intercourse with 3 or more male sex partners during the last 6 months;

Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;

Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;

Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or

At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;

Tests HIV antibody negative at time of screening;

Willing to provide locator information to study staff;

Willing to take pre-exposure prophylaxis (PrEP);

Willing to participate in behavioral intervention;

Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and

Does not have a job or other obligations that would require long absences from the AMTU study area (greater than 4 weeks at a time).

Intoxicated or under the influence of alcohol or other drugs at the time of consent;

Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty making the judgment.);

History of bone fractures not explained by trauma;

Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;

Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min, or serum creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;